Rheumatoid ArthritisNCT02648035
EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 26 sites in Greece.
Trial summary
The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 26 sitesGreece
- Study dates
- 22 Sep 2016to 20 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.
Who may be able to join
- Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.
Who cannot join
- Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.
- Participants who have received TCZ in past treatments.
- Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.
- Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Greece26 sites
Private Practice Rheumatology, Merantzis
Agrinio, 301 00
Private Practice Rheumatology, Stavropoulos
Áno Patísia
Rheumatology Private Practice
Athens, 11521
General Hospital of Athens KAT, Rheumatology
Athens, 14527
Rheumatology Private Practice
Athens
Rheumatology Private Practice
Chania, 731 00
Private Practice Rheumatology, Papadimitriou
Drama, 66132
Rheumatology Private Practice
Eleusina, 19200
ATTIKO Hospital_4th University Internal Medicine Clinic
Haidari, 124 62
Private Practice Rheumatology, Georgiadis
Ioannina, 453 33
Rheumatology Private Practice
Kalithea, Athens, 17673
Private Practice Rheumatology, Kotrotsios
Karditsa, 431 00
General Hospital of Kavala; Rheumatology
Kavala, 65500
Rheumatology Private Practice
Kifissia
Private Practice Rehumatology, Ziogas
Larissa, 412 21
General Hospital of Mytilini, Rheumatology
Mytilene, 811 00
Private Practice Rheumatology, Trontzas
Néa Smýrni, 171 21
Rheumatology Private Practice
Pátrai, 26221
Olympion Medical Center of Patras, Internal Medicine Clinic
Pátrai, 26443
Private Practice Rheumatology, Psaltis
Serres, 621 22
Rheumatology Private Practice
Serres, 62122
Rheumatology Private Practice
Thessaloniki, 54621
General Hospital Agios Pavlos
Thessaloniki
Rheumatology Private Practice
Thessaloniki
Rheumatology Private Practice
Véroia, 59100
Rheumatology Private Practice
Volos, 38221
About this study
Official title: Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.
The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabBiological
Also called ACTEMRA
Subcutaneous Tocilizumab according to approved label.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Tocilizumab | Participants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label. Receives: Biological: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
Measured: At 52 weeks
Secondary outcomes (14)
Health Assessment Questionnaire (HAQ) Score
Measured: At baseline, 24 and 52 weeks
Visual Analog Scale (VAS) Pain Score in a 100 mm Scale
Measured: At baseline, 24 and 52 weeks
Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale
Measured: At baseline, 24 and 52 weeks
Percentage of Participants with Clinically Significant Changes in Laboratory Values
Measured: At baseline, 24 and 52 weeks
Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy
Measured: At baseline, 24 and 52 weeks
Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)
Measured: At baseline, 24 and 52 weeks
Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs)
Measured: Up to 52 weeks
Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs
Measured: Up to 52 weeks
Percentage of Participants with IEs with Laboratory Abnormalities
Measured: Up to 52 weeks
Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs
Measured: Up to 52 weeks
Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs
Measured: Up to 52 weeks
Percentage of Participants on Glucocorticoids (GCs) with AEs
Measured: Up to 52 weeks
Disease Activity Score 28 (DAS28)
Measured: At baseline, 24 and 52 weeks
Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)
Measured: At baseline, 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start22 Sep 2016
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648035
- Sponsor's protocol ID
- ML29855
- Status last verified
- Mar 2019
- First submitted
- 5 Jan 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.
- ClinicalTrials.gov ID
- NCT02648035
- Acronym / sponsor ID
- ML29855
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Tocilizumab | – | Biological: TocilizumabParticipants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.
Key inclusion criteria (1 listed)
- Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.
Key exclusion criteria (4 listed)
- Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.
- Participants who have received TCZ in past treatments.
- Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.
- Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: ACTEMRASubcutaneous Tocilizumab according to approved label. | Biological | Subcutaneous Tocilizumab |
Primary outcome
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
Time frame: At 52 weeks
14 secondary outcomes
Health Assessment Questionnaire (HAQ) Score
Time frame: At baseline, 24 and 52 weeks
Visual Analog Scale (VAS) Pain Score in a 100 mm Scale
Time frame: At baseline, 24 and 52 weeks
Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants with Clinically Significant Changes in Laboratory Values
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs)
Time frame: Up to 52 weeks
Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs
Time frame: Up to 52 weeks
Percentage of Participants with IEs with Laboratory Abnormalities
Time frame: Up to 52 weeks
Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs
Time frame: Up to 52 weeks
Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs
Time frame: Up to 52 weeks
Percentage of Participants on Glucocorticoids (GCs) with AEs
Time frame: Up to 52 weeks
Disease Activity Score 28 (DAS28)
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)
Time frame: At baseline, 24 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 26 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation (time frame: At 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.